AORN Guidance Statement:
Reuse of Single-Use Devices
Introduction
Today’s economic environment has compelled
health care organizations to explore methods to
reduce health care costs. One prospective
approach to controlling rising costs is to reprocess
single-use medical devices. Reprocessing is rigor-
ously regulated by the US Food and Drug Adminis-
tration (FDA). AORN, the Association of periOpera-
tive Registered Nurses, recognizes the need for
each health care facility to provide safe, cost-effec-
tive, quality care to patients and realizes that many
facilities in today’s marketplace are reprocessing
and reusing devices labeled for single use. These
devices are reprocessed either within the facility or
by an external third party contracted to provide the
reprocessing service.
Background
As surgery evolved and increased in complexity, the
number of single-use devices utilized during surgery
increased and continues to rise. In response to this
trend, the practice of reprocessing and reusing single-
use medical devices began during the 1970s.1 As
technology led to a wide variety of materials used in
device manufacture and devices became more com-
plex, concern for patient safety, informed consent,
and ethical practice intensified. In the late 1990s, the
FDA determined that increased regulation of repro-
cessing was needed to promote safe practice and
protect the public’s safety. Although original equip-
ment manufacturers have been regulated for many
years, the FDA determined that they, along with
third-party reprocessors and hospital reprocessors,
should be regulated uniformly according to the Food,
Drug, and Cosmetic Act. The FDA sought the expert-
ise of manufacturers, reprocessors, hospitals, users,
and other interested parties in developing a regula-
tory document, and in August 2000, it published its
rule governing the reprocessing/reusing of devices
labeled for single-use only. The document is applica-
ble to both hospitals and third-party reprocessors.
Reprocessing of single-use devices (SUDs) is addi-
tionally addressed in the Medical Device User Fee
and Modernization Act of 2002 (MDUFMA), which
establishes new statutory requirements for SUDs,
including labeling to identify the devices as
reprocessed, submission of validation data for many
reprocessed SUDs, and submission of premarket
2006 Standards, Recommended Practices, and Guidelines
notification (510[k]) with validation data for some
SUDs that previously were exempt from 510(k) sub-
mission requirements. Firms and hospitals that are
reprocessing are considered by the FDA as manufac-
turers and therefore must comply with statutory and
regulatory requirements.2 In addition, the FDA has
published an approved list of single-use devices that
are acceptable for reprocessing and a list of items
that may not be reprocessed. In essence, the regula-
tions regard reprocessors in the same way as original
equipment manufacturers.3,4
Guidance Statement
Reprocessing single-use medical devices is chosen
by some health care facilities as a cost containment
effort and to reduce the amount of waste generated.
It is the role and responsibility of each health care
facility to determine whether and to what extent it
will engage in such practice. As licensed profession-
als, perioperative nurses must demonstrate account-
ability to the nursing profession, to other members
of the health care team, and to the public they
serve.5 AORN, the professional organization of and
for perioperative nurses, believes certain basic tenets
must underpin any reprocessing program. The fore-
most concern is for the patient’s safety. Therefore,
♦ if a device cannot be cleaned, it cannot be
reprocessed and reused;
♦ if sterility of a post-processed device cannot
be demonstrated, the device cannot be
reprocessed and reused;
♦ if the integrity and functionality of a
reprocessed SUD cannot be demonstrated
and documented as safe for patient care
and/or equal to the original device specifica-
tions, the device cannot be reprocessed and
reused; and
♦ if anything is opened it needs to be decon-
taminated before reprocessing.
Per requirements of the MDUFMA regulation,
the FDA has published a list of reprocessed SUDs
that have 510(k) approval/clearance; whose manu-
facturers have provided supplemental data on
functionality, cleaning, and sterility; and which
now are on the published list of devices that are
acceptable for reprocessing.2
Although some operational savings may be real-
ized by reusing certain devices, any cost-benefit
analysis would necessarily include labor costs;
309
Reuse of Single-Use Devices
program costs, including quality system require-
ments such as sterility and post-processing device
testing (see section on quality system require-
ments); documentation costs; and the potential
cost of device failure. Using the results of a thor-
ough cost-benefit analysis, each provider facility
must make an informed choice as to whether it
wishes to invest the necessary resources to develop
a safe reprocessing system within the facility. Use
of an external reprocessor presents a different, but
related, set of factors for consideration. When a
decision is made in favor of using an external
reprocessing company, it is the user facility’s
responsibility to assess the quality of services pro-
vided under the contractual arrangement.6 The user
facility should review the processes used by the
contracted agent and determine whether correct
procedures are being followed. 7 Regardless of
whether an internal reprocessing program is devel-
oped or an external reprocessing company is
selected, the user facility should be aware that the
FDA views any reprocessor as a manufacturer and,
as such, subject to federal regulations.3,8,9
Federal Regulatory Requirements
In August 2000, the FDA issued guidance on the
practice of reprocessing and reusing medical
devices intended to be used only once. The FDA’s
goal in issuing this regulation was to ensure a
reprocessing and reuse regulatory program that is
based on good science and protects the public
health. At the same time, the FDA intended to
ensure equitable regulatory requirements for all
parties engaged in reprocessing. In the guidance
document,10 the FDA indicates that hospitals and
third parties that reprocess SUDs are subject to the
same regulations as the original equipment manu-
facturers. The MDUFMA also addressed reprocess-
ing of SUDs by amending the federal Food, Drug
and Cosmetic Act (the Act) and establishing new
statutory requirements applicable to reprocessed
SUDs, including requirements for
♦ quality system regulations,
♦ medical device reporting,
♦ registration and listing,
♦ labeling,
♦ premarket approval and premarket notification,
♦ medical device corrections and removals, and
♦ medical device tracking.2
310
Quality System Regulation
All manufacturers, including hospital and third-party
reprocessors, are subject to the FDA Good Manufac-
turing Practices (GMP) requirements. These require-
ments are presented in the quality system regulation
that governs the methods, facilities, and controls
used for designing, manufacturing, packaging, label-
ing, storing, installing, and servicing medical
devices.3 Quality system refers to the organizational
structure, responsibilities, procedures, processes, and
resources for implementing quality management. For
device manufacturers, including reprocessors, this
system is required in addition to any quality improve-
ment program that may be in place as required by
other regulatory bodies. The quality system regula-
tion addresses the areas shown in Table 1.11
Medical Device Reporting (MDR)
Under MEDWATCH, the FDA’s medical device
reporting program resulting from the Safe Medical
Devices Act of 1990 (Public Law 101-629),12 both
manufacturers and users are required to report deaths
or serious injuries to the FDA if it can be reasonably
determined that a medical device may have caused
or contributed to the incident. Manufacturers also
must report certain device malfunctions.13 Because
the FDA considers reprocessors to be manufacturers
when they reprocess an SUD,9 hospital reprocessors
have dual reporting responsibility. They are subject to
manufacturer’s reporting requirements (21 CFR, Part
803 Subpart E)14 as well as those for the device user
facility (21 CFR, Part 803, Subparts A and C).15,16
Although user facilities must report only deaths or
serious injury, manufacturers’ reporting requirements
are more extensive and require additional supple-
mental information. Manufacturers (reprocessors)
also must report any event that requires the manufac-
turer (reprocessor) to take immediate remedial
action. The Jan 26, 2000, issue of the Federal Register
contains the most recent MDR requirements. Hospi-
tals that reprocess SUDs are subject to both user
facility reporting and the more comprehensive manu-
facturer reporting requirements.17
Registration and Listing
All persons or entities owning or operating estab-
lishments that manufacture, prepare, or process
devices must register with the FDA. The FDA uses
2006 Standards, Recommended Practices, and Guidelines
 Reuse of Single-Use Devices

Table 1
QUALITY SYSTEM REGULATION1
Area Addressed Code of Federal Regulations
Management responsibility 21 CFR, Part 820.20, 22, 25

Design controls 21 CFR, Part 820.30

Document controls 21 CFR, Part 820.40

Purchasing controls 21 CFR, Part 820.50

Product identification and traceability 21 CFR, Part 820.60, 65

Production and process validation 21 CFR, Part 820.70, 72, 75

Acceptance activities such as inspections, tests, or other 21 CFR, Part 820.80, 86

verification activities
Nonconforming product control 21 CFR, Part 820.90

Corrective and preventive action 21 CFR, Part 820.100

Labeling and packaging controls 21 CFR, Part 820.120, 130

Handling, storage, distribution, and installation controls 21 CFR, Part 820.120, 140, 150, 160

Records including device master record, device history 21 CFR, Part 820.180, 181, 184, 186, 198
record, quality system record, and complaint files controls
Servicing controls 21 CFR, Part 820.200

Use of statistical techniques to establish, control, and verify the 21 CFR, Part 820.250
acceptability of process capability and product characteristics
1. “Quality system regulation,” CFR 21 Part 820, US Food and Drug Administration, http://www.accessdata.fda.gov/
scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=820 (accessed 3 Oct 2005).

this information to identify and locate establish- ♦ FDA classification name,

ments that it is required to inspect. When register-
ing, the following information must be provided:
♦ name and address,
♦ business names used,
♦ business name of owner or operator, and
♦ establishment type.
When registering for the first time, a specific
FDA form is required. An additional registration
form must be submitted annually thereafter. In
addition to registering with the FDA, each repro-
cessing entity must provide a list of the devices it
intends to reprocess. A separate listing form must
be submitted for each device to be reprocessed.
Devices are listed by category. The following infor-
mation is required:
♦ FDA product code,
♦ brand name, and
♦ common or usual name.
Additional information about registration and
listing is available in the Code of Federal Regula-
tions (21 CFR, Part 807).18 The necessary forms can
be obtained from the Office of Compliance, Center
for Devices and Radiologic Health (HFZ-307), US
Food and Drug Administration, 2094 Gaither Road,
Rockville, MD 20850. The Center for Devices and
Radiologic Health (CDRH) offers an additional
document, CDRH Guidance for Industry: Instruc-
tions for Completion of Medical Device Registra-
tion and Listing Forms FDA 2891, 2891a, and
2892. This document can be obtained from the

2006 Standards, Recommended Practices, and Guidelines 311

Reuse of Single-Use Devices
Division of Small Manufacturers Assistance
(DMSA) at telephone number 800-638-2041 or
301-638-2041; e-mail DMSA@CDRH.fda.gov.
Labeling
The FDA directions for labeling can be found in 21
CFR, Part 801.19 The term labeling includes package
inserts as well as the information printed on the
actual label of the package. Labeling requirements
include the name and location of the manufacturer
(reprocessor) and adequate direction for the device’s
intended use. If the manufacturer (reprocessor)
knows of uses other than the intended use of the
device, FDA requires the manufacturer (reprocessor)
to provide adequate labeling for alternate uses of the
device as are known. In addition, MDUFMA added
new labeling requirement for reprocessed SUDs
(Section 502[v] of the Act). Beginning after January
26, 2004, reprocessed SUDs that are introduced into
interstate commerce must prominently and conspic-
uously bear the statement “Reprocessed device for
single use. Reprocessed by [insert the name of the
manufacturer that reprocessed the device].”2 For
additional information about labeling requirements,
obtain a copy of the FDA guidance document Label-
ing Regulatory Requirements for Medical Devices
from http://www.fda.gov/cdrh/dsma/470.pdf or con-
tact the Division of Small Manufacturers Assistance
(DSMA) by phone at 800-638-2041 or 301-638-
2041; e-mail DMSA@CDRH.fda.gov.
Premarket Approval and
Premarket Notification
After registering with the FDA and submitting a list
of devices to be manufactured (reprocessed) and
distributed for use, the registered entity must meet
premarket submission requirements for each listed
device. Certain devices may be exempt from the
premarket submission requirement. If exempt, the
device need only be listed with the FDA. Additional
information about exemptions can be found in 21
CFR, Part 807.75.20 The FDA has defined a phase-in
period for premarket submissions to accommodate
entities that are presently engaged in reprocessing.
Following the phase-in period, a premarket submis-
sion must be submitted for any new device to be
manufactured (reprocessed) at least 90 days before
beginning distribution of the device.
312
There are two types of premarket submissions: a
premarket notification, or 510(k), and a premarket
approval (PMA) application. The type of submission
required is based on the device classification, as
defined in 21 CFR, Part 814.21 Unless specifically
exempted, a premarket notification (510[k]) is
required for all Class I and Class II devices. A premar-
ket notification (510[k]) submission must contain
enough information for the FDA to determine whether
the particular device is “substantially equivalent” to
another device that has been previously judged to be
safe and effective and has been cleared for market-
ing/reprocessing. The predicate device selected must
have the same intended use as the device for which
the 510(k) is submitted. The predicate device may be
the original SUD of the original equipment manufac-
turer (OEM) provided that the 510(k) compares the
unique characteristics of the submitted device to
those of the predicate device so the FDA can deter-
mine equivalency with respect to safety and effective-
ness. The following information is required for a pre-
market notification (510[k]) submission:
♦ device trade name, proprietary name, usual
name, or classification name;
♦ entity registration number;
♦ device classification;
♦ action taken to determine device perform-
ance standards;
♦ proposed labels, labeling, and advertisements
to describe the device, its intended use, and
the directions for its use, including photos
and/or engineering drawings if appropriate;
♦ appropriate data to show that the registered
entity has considered the consequences and
effects any changes or modifications in the
device might have on the safety and effective-
ness of the device;
♦ 510(k) summary or 510(k) statement as
defined in 21 CFR, Part 807.92, 93;22
♦ financial disclosure statement;9
♦ statement certifying truth, accuracy, and com-
pleteness of material submitted; and
♦ any other information requested by the FDA.
For specific guidance on preparing 510(k) sub-
missions, consult Regulatory Requirements for Med-
ical Devices, available at http://www.fda.gov/cdrh
/manual/510kprt1.html, or contact the Division of
Small Manufacturers Assistance. Locate other rele-
vant guidelines at http://www.accessdata.fda.gov
/scripts/cdrh/cfdocs/cfGGPSearch.CFM.
2006 Standards, Recommended Practices, and Guidelines

All Class III devices require a PMA. A PMA appli-
cation must include valid scientific evidence demon-
strating the safety and effectiveness of the original
and/or reprocessed device. Each PMA application
should evaluate the unique characteristics of the sub-
mitted device. Clinical data (eg, results of clinical tri-
als) may be required. Some clinical trials require FDA
approval of an investigational device exemption
(IDE) application for the device(s) to be studied. For
additional information, consult the following sources:
♦ 21 CFR, Part 814.20;21
♦ 21 CFR, Part 812;22
♦ Device Advice: Premarket Approval (PMA),
available at http://www.fda.gov/cdrh/devadvice
/pma (accessed 3 Oct 2005);
♦ Guidance for Institutional Review Boards and
Clinical Investigators, “Significant risk and
nonsignificant risk medical device studies,”
available at http://www.fda.gov/oc/ohrt
/irbs/devices.html (accessed 3 Oct 2005); and
♦ Device Advice: Clinical Trials and Investiga-
tional Device Exemption (IDE), available at
http://www.fda.gov/cdrh/devadvice/ide
/application.shtml (accessed 3 Oct 2005).
The FDA also requires a satisfactory inspection of
the manufacturing (reprocessing) facilities before
approving a PMA application. The application should
include a comprehensive manufacturing (reprocess-
ing) section that clearly identifies all manufacturing
(reprocessing) controls. Under MDUFMA, some
SUDs that previously were exempt from 510(k) sub-
mission requirements under Sections 510(l) or (m) of
the Act are no longer exempt and are required under
Section 510(o)(2) of the Act to submit 510(k) notifica-
tions that include validation data. Validation data also
was required for some reprocessed SUDs that already
had been cleared under 510(k). Under Section 510(o)
of the Act, reprocessors that either did not submit val-
idation data for those reprocessed SUDs within speci-
fied time frames or received “not substantially equiva-
lent letters” from the FDA can no longer legally
market those reprocessed devices. Finally, under Sec-
tion 515(c)(2) of the Act, reprocessors of Class III
SUDs are required to submit premarket reports
instead of premarket approval applications.2
Medical Device
Corrections and Removals
Device correction and/or removal from the point of
use must be promptly reported to the FDA when the
2006 Standards, Recommended Practices, and Guidelines
Reuse of Single-Use Devices
correction or removal is initiated by the manufacturer
(reprocessor) to reduce a health risk to the user or to
correct a violation of the Food, Drug, and Cosmetic
Act. For example, if a facility reprocessed an SUD
that resulted in a patient’s adverse reaction and the
hospital chose to remove the remainder of the lot of
those reprocessed SUDs from circulation to decrease
the possibility of other patients having adverse reac-
tions, that action would be a removal and the facility
would be required to report the removal to the FDA.
Corrections are defined as
the repair, modification, adjustment, relabel-
ing, destruction, or inspection of a device with-
out its physical removal from its point of use.23
Removal is defined as
the physical removal of a device from its
point of use to some other location for repair,
modification, adjustment, relabeling, destruc-
tion, or inspection.23
Distributed devices withdrawn from the market-
place due to a minor violation of the Food, Drug,
and Cosmetic Act or as a matter of stock rotation
need not be reported. Stock recoveries need not be
reported, nor should devices removed for routine
servicing. The term stock recoveries refers to
devices that have been prepared for use, but have
not left the physical premises and jurisdiction of
the manufacturer (reprocessor)—eg, devices that
have not left the reprocessing area. However, each
correction and/or removal must be documented
regardless of whether it is reported to the FDA.
When a report must be filed with the FDA, the
report must be filed within 10 days of the correc-
tion/removal action. The report should include the
following information:
♦ registration number of the entity manufactur-
ing/reprocessing the device;
♦ date of the report;
♦ sequence number of the report from that entity;
♦ name, address, and telephone number of the
reporting entity;
♦ name, title, address, and telephone number
of individual responsible for the correction/
removal action;
♦ brand name, classification name, and com-
mon name of the device and its intended use;
♦ marketing status of the device;
♦ model, catalog, and code number of the
device and the manufacturer’s (reprocessor’s)
lot, serial, or other identification number for
the device;
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Reuse of Single-Use Devices
♦ description of event leading to correction/
removal action;
♦ any injuries resulting from device use;
♦ total number of devices manufactured
(reprocessed) subject to the correction/
removal action;
♦ date of manufacture/distribution/reprocessing
and expected shelf life of the device;
♦ name, address, telephone number of all to
whom the device has been distributed and the
number of devices distributed to each; and
♦ copies of all communication regarding the cor-
rection/removal action and the names and
address of all recipients of the communication.
For additional information about correction and
removal requirements, consult 21 CFR, Part 806.
Medical Device Tracking
Medical device tracking is intended to ensure that
manufacturers (reprocessors) of certain devices can
locate those devices should corrective action and/or
notification about such devices become necessary.
Original equipment manufacturers are subject to the
medical device tracking regulation only when the
FDA issues a tracking order for a device manufactured
by the OEM. Reprocessors are subject to the medical
device tracking regulation only when the FDA issues
an order for the specific device(s) being reprocessed.
For additional information on device tracking, includ-
ing the types of devices currently subject to tracking
orders, consult Guidance on Medical Device Track-
ing, available at http://www.fda.gov/cerh/modact/
tracking/pdf or from the Center for Devices and Radi-
ologic Health (CDRH) at 301-827-0111. Request
document number 169.
Definitions
Class I medical device: A medical device for
which general controls provide reasonable assur-
ance of the safety and effectiveness of the device
or, if there is insufficient evidence to reasonably
ensure safety and effectiveness, the device is not
life-supporting or life-sustaining, its use is not sub-
stantially important in preventing impairment of
human health, and/or its use “does not present a
potential unreasonable risk of illness or injury.”23
Class II medical device: A medical device for
which general controls alone do not provide reason-
314
able assurance of device safety and effectiveness but
for which there is sufficient information to establish
special controls (eg, performance standards, guide-
lines, patient registries, postmarket surveillance) to
provide that assurance.23
Class III medical device: A medical device for
which neither general controls nor special controls
provide reasonable assurance of device safety and
effectiveness and the device is life-supporting or
life sustaining or its use “is of substantial impor-
tance in preventing impairment of human health”
or “presents a potential risk of illness or injury.”23
Opened-but-unused device: A device whose
sterility is compromised before being introduced
onto the sterile field and which is not contami-
nated with blood and/or other potentially infec-
tious materials (OPIM) external to the sterile field.24
Reprocessing: Includes all operations to render a
contaminated reusable or single-use device patient
ready. Single-use devices to be reprocessed may be
either used or unused. Reprocessing steps include
cleaning, decontamination, and sterilization/
disinfection.9
Resterilization: The repeated application of a
process intended to remove or destroy all viable forms
of microbial life, including bacterial spores.9 Because
sterility is not an absolute, the accepted sterility assur-
ance level (SAL) is usually defined as 10–6.
Reuse: The repeated or multiple uses of any
medical device whether marketed as reusable or
single-use. Repeated/multiple use may be on the
same patient or on different patients with applica-
ble reprocessing of the device between uses.25
Single-use device (SUD): A device intended by the
manufacturer to be used on one patient during one
procedure. The device is not intended for reprocess-
ing and/or use on another patient or on the same
patient at another time. Device labeling may or may
not identify the device as single-use or disposable, but
manufacturer instructions for reprocessing are absent.9
Third-party reprocessor: A business establish-
ment, separate from the user facility and the device
manufacturer, one of whose primary businesses is
to reprocess single-use/disposable medical devices.
NOTES
1. “Reuse of single-use devices,” AORN Journal 73
(May 2001) 957-966.
2. “Medical Device User Fee and Modernization Act
(MDUFMA) of 2002,” PL 107-250, 107th Congress,
http://www.fda.gov/cdrh/mdufma (accessed 3 Oct 2005).
2006 Standards, Recommended Practices, and Guidelines

3. “Guidance for industry and for FDA staff: Enforce-
ment priorities for single-use devices reprocessed by third
parties and hospitals,” (Aug 14, 2000) US Food and Drug
Administration, http://www.fda.gov/cdrh/reuse/1168.html
(accessed 3 Oct 2005).
4. “Medical devices; reprocessed single-use devices;
termination of exemptions from premarket notification;
requirement for submission of validation data,” US Food
and Drug Administration, http://www.fda.gov/OHRMS
/DOCKETS/98fr/03-16109.html (accessed 3 Oct 2005).
5. “AORN explications for perioperative nursing,” in
Standards, Recommended Practices, and Guidelines
(Denver: AORN, Inc, 2005) 86-115.
6. Joint Commission on Accreditation of Healthcare
Organizations, “Standard LD.3.50: Services provided by
consultation, contractual agreements, or other agree-
ments are provided safely and effectively,” in Compre-
hensive Accreditation Manual for Hospitals (Oakbrook
Terrace, Ill: Joint Commission on Accreditation of
Healthcare Organizations, 2005) LD 13.
7. “Letter re: Reusable medical devices rented or
leased from third parties,” US Food and Drug Administra-
tion, http://www.fda.gov/cdrh/comp/rentleasethird.html
(accessed 23 Aug 2005).
8. “Quality system regulation, Definitions,” CFR 21,
Part 820.3, US Food and Drug Administration, http://
www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR
/CFRSearch.cfm?fr=820.3 (accessed 3 Oct 2005).
9. “Letter to American College of Healthcare Execu-
tives: Reuse of single-use or disposable medical
devices,” US Food and Drug Administration, http://
www.fda.gov/cdrh/comp/policymayaply.html (accessed
3 Oct 2005).
10. Center for Devices and Radiological Health, US
Food and Drug Administration, US Department of Health
and Human Services, Enforcement Priorities for Single-
Use Devices Reprocessed by Third Parties and Hospitals
(Washington, DC: US Government Printing Office, Aug
14, 2000).
11. “Quality system regulation,” CFR 21, Part 820, US
Food and Drug Administration, http://www.accessdata
.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFR
Part=820 (accessed 3 Oct 2005).
12. “Safe Medical Devices Act of 1990,” Public Law
101-629, http://thomas.loc.gov/cgi-bin/query/C?c101:./temp
/~c101exIXhd (accessed 23 Aug 2005).
13. “Medical device reporting: General provisions,”
CFR 21, Part 803.1, US Food and Drug Administration,
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr
/CFRSearch.cfm?fr=803.1 (accessed 3 Oct 2005).
14. “Manufacturer reporting requirements,” CFR 21,
Part 803, Subpart E, US Food and Drug Administration,
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr
/CFRSearch.cfm?CFRPart=803 (accessed 23 Aug 2005).
15. “Medical device reporting: General provisions,”
CFR 21, Part 803, Subpart A, US Food and Drug Adminis-
2006 Standards, Recommended Practices, and Guidelines
Reuse of Single-Use Devices
tration, http://www.accessdata.fda.gov/scripts/cdrh
/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=803 (accessed 23
Aug 2005).
16. “User facility reporting requirements,” CFR 21,
Part 803, Subpart C, US Food and Drug Administration,
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr
/CFRSearch.cfm?CFRPart=803 (accessed 23 Aug 2005).
17. US Department of Health and Human Services,
“Medical device reporting: Manufacturer reporting,
importer reporting, user facility reporting, distributor
reporting,” Federal Register 65 (Jan 26, 2000) 4112-4121.
18. “Establishment regulation and device listing for
manufacturers and initial importers of devices,” CFR 21,
Part 807, US Food and Drug Administration, http://www
.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFR
Search.cfm?CFRPart=807 (accessed 23 Aug 2005).
19. “Labeling,” CFR 21, Part 801, US Food and Drug
Administration, http://www.accessdata.fda.gov/scripts
/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=801
(accessed 23 Aug 2005).
20. “Exemption from premarket notification,” CFR 21,
Part 807.65, US Food and Drug Administration, http://www
.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm
?fr=807.65 (accessed 23 Aug 2005).
21. “Premarket approval of medical devices,” CFR 21,
Part 814, US Food and Drug Administration, http://www
.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm
?CFRPart=814 (accessed 23 Aug 2005).
22. “Investigational device exemptions,” CFR 21, Part
812, US Food and Drug Administration, http://www.access
data.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFR
Part=812 (accessed 3 Oct 2005).
23. “Medical devices: Reports of corrections and
removals, definitions,” CFR 21, Part 806.2, US Food and
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